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首页> 外文期刊>Advances in therapy. >Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis
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Cardiovascular Risks, Bleeding Risks, and Clinical Events from 3 Phase III Trials of Pirfenidone in Patients with Idiopathic Pulmonary Fibrosis

机译：特发性肺纤维化患者的3期二苯基三期试验的心血管风险，出血风险和临床活动

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Introduction This study assessed baseline cardiovascular (CV) risk factors, concomitant CV medication use, risk of major adverse cardiac events-plus (MACE-plus), and bleeding adverse events (AEs) in patients with idiopathic pulmonary fibrosis (IPF) in three randomized, placebo-controlled phase III trials of pirfenidone. Methods Patients in the pirfenidone phase III trials were included. Patients with unstable or deteriorating cardiac disease within 6 months before enrollment were ineligible. Medical history at baseline and concomitant CV medication use during treatment were reported. A retrospective, blinded review of AE preferred terms was conducted to identify MACE-plus and bleeding events. Subgroup analyses examined the impact of concomitant CV medication use on how pirfenidone treatment affected clinical outcomes. Results In total, 1247 patients were included [n = 623 pirfenidone (2403 mg/day) and n = 624 placebo]. The median age was 68 years, 74% were male, and 65% were current/former smokers. Commonly reported CV risk factors included hypertension (52%), obesity (44%), hypercholesterolemia (23%), and hyperlipidemia (23%). Pre-existing cardiac disorders included coronary artery disease (16%), myocardial infarction (5%), and atrial fibrillation (5%). Lipid-modifying agents (60%), antithrombotic agents (54%), and renin-angiotensin inhibitors (39%) were commonly used concomitant CV medications. The incidences of MACE-plus and bleeding events were similar between the pirfenidone and placebo groups (1.8% and 2.9% for MACE-plus events and 3.7% and 4.3% for bleeding events, respectively). Except for patients receiving heparin, pirfenidone had a beneficial effect compared with placebo on efficacy outcomes regardless of concomitant CV medications. Conclusions CV risk factors and comorbidities and use of concomitant CV medications are common in patients with IPF. Pirfenidone did not appear to increase the risk of CV or bleeding events. Use of several concomitant CV medications, including warfarin, did not appear to adversely impact pirfenidone's beneficial effect on efficacy outcomes. Funding F. Hoffmann-La Roche Ltd. and Genentech, Inc.
机译：简介本研究评估了基线心血管（CV）危险因素，伴随的CV药物用途，主要不良心脏事件的风险 - 患者有特发性肺纤维化（IPF）的患者（MACE-PLUS）和出血不良事件（AES）三次随机，Pirfenidone的安慰剂对照期III试验。方法包括Pirefenidone期III试验中的患者。患者在入学前6个月内不稳定或恶化的患者不合格。报道了基线的病史和伴随治疗过程中的CV药物用途。对AE优选的术语进行了回顾性的，盲目的审查，以鉴定MACE-PLUS和出血事件。亚组分析检测了伴随的CV药物用途对Pirfenidone治疗如何影响临床结果的影响。结果总共包括1247名患者[n = 623 pirefenidone（2403 mg /天）和n = 624安慰剂]。中位年龄为68岁，74％是男性，65％是当前/前吸烟者。常见报道的CV风险因素包括高血压（52％），肥胖（44％），高胆固醇血症（23％）和高脂血症（23％）。预先存在的心脏病包括冠状动脉疾病（16％），心肌梗死（5％）和心房颤动（5％）。脂质改性剂（60％），抗血栓形成剂（54％）和肾素 - 血管紧张素抑制剂（39％）常用伴随的CV药物。 Pirfenidone和安慰剂组之间的术术 - 加和出血事件的发病率类似于分别为出血事件的比例组（Mace-Plus赛事1.8％和2.9％）。除了接受肝素的患者外，Pirfenidone与安慰剂伴有疗效结果相比具有有益的效果，无论伴随的CV药物如何。结论IPF患者患有CV危险因素和伴随CV药物的使用以及伴随的CV药物。 Pirefenidone似乎没有增加CV或出血事件的风险。使用包括华法林，包括华法林，包括华法林的几种伴随的CV药物并未对吡芬酮对疗效结果的有益作用产生不利影响。资助F. Hoffmann-La Roche Ltd.和Genentech，Inc。

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